CLINICAL TRIAL TO COMPARE EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OF DOXOPHYLLINE 800 mg SR AND MONTELUKAST 10 mg WITH DOXOPHYLLINE 800mg SR IN SUBJECTS SUFFERING WITH ACUTE BRONCHOSPASM

Phase 3

Completed

• Conditions: Health Condition 1: null- patient suffering with Acute BRONCHOSPASM OF DIFFERENT ETIOLOGY

• Registration Number: CTRI/2009/091/001041
• Lead Sponsor: Swiss Garnier Life SciencesNo. 68A, Vembuli Amman koli St, Alandur, Chennai 600016 .Phone : 044-22329837, 22312892

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Patients of either sex of age >= 18 and <= 70 years.

Patient suffering from mild to moderate bronchospasm of different etiology.

PEF between 50% to 80 % (mild to moderate)by using Peak flow meter.

Pre menopausal women must use the appropriate contraception.

Patient willing to give informed consent.

Exclusion Criteria

Patients with significant pulmonary insufficiency, including both intrinsic lung disease and Respiratory failure i.e. severe bronchospasm

Patient with a history of known hypersensitivity from any one of the said medication.

Patients with acute myocardial infarction, hypotension.

Patients with uncontrolled hypertension.

Bronchospasm of anaphylactic, mechanical or cancerous origin.

Subjects with severe hepatic, renal failure or encephalopathy.

Chronic alcoholics.

Patients with history of cardiac surgery.

Pregnant & lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare efficacy of the FDC of Doxophylline 800 mg SR and Montelukast 10 mg against Doxophylline 800 mg SR in subjects suffering with acute bronchospasm of different etiology.Timepoint: 10 DAYS

Secondary Outcome Measures

Name	Time	Method
To compare the safety &amp; tolerability of FDC of Doxophylline 800 mg SR and<br>Montelukast 10 mg against Doxophylline 800 mg SR on oral administration in subjects suffering with acute bronchospasm of different etiology<br>Timepoint: 10 DAYS